Replication of the SEPRA Diabetes Trial in Healthcare Claims Data

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Replication of the SEPRA Diabetes Trial in Healthcare Claims Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05577728
• Other study ID #: 2018P002966-DUP-SEPRA
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Description:

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2316
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

All patients will be required to have continuous enrollment during the baseline period of 180 days before initiation of semaglutide or standard of care (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) (cohort entry).

Eligible cohort entry dates:

Market availability of semaglutide/standard of care in the US started on December 6th, 2017:

• For Optum: December 6, 2017 - June 30, 2021 (end of data availability)

Inclusion Criteria:

• Age >= 18

• Type 2 diabetes mellitus diagnosis

• Use of metformin

• At least 2 HbA1c records within the prior 280 days

• At least 1 HbA1c record >= 7% within the prior 90 days

Exclusion Criteria:

• Missing age or gender

• Use of any other anti-diabetes medications

• Any insulin use

• Pregnancy

• Multiple Endocrine Neoplasia syndrome type 2

• CKD stage 5, ESRD, dialysis, or renal transplant

• Nursing home admission

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• New use of semaglutide injection
New use of semaglutide injection dispensing claim is used as the exposure.
• New initiation of "standard of care" (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral)
New initiation of "standard of care" (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) dispensing claim is used as the reference.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term glycemic control defined as proportion of patients who will achieve an HbA1c of less than 7.0% (53.0 mmol/mol)	Number of subjects	At year 1
Secondary	Change in HbA1c	Change in HbA1c from baseline at 365 days after drug initiation.	At 1 year
Secondary	Number of hypoglycemic episodes leading to an inpatient admission or emergency room encounter.		At 1 year